FDA 510(k) clearances — page 61
clearances on record, most recent first.
Clearances — page 61
6,001–6,100 of 176,479- K243071 — Bovine Dermis Collagen Dermal Matrix
- K243094 — Quickdent Dental Implant System
- K243169 — The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ceftobiprole in the dilution range of 0.008-16 ug/mL
- K243171 — Yushan X-Ray Flat Panel Detector
- K243361 — Nutrifit
- K243430 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
- K243440 — Electric Wheelchair (HC820N)
- K243595 — OviTex PRS (Long-Term Resorbable)
- K243652 — Monoject Enteral Syringe with ENFit Connector (6 models)
- K243688 — Saige-Dx (3.1.0)
- K243705 — Saige-Density (2.5.0)
- K243725 — BD Vaginal Panel
- K240763 — FirstFit Surgical Kit
- K240765 — Porous Biologic Scaffold
- K240959 — Respiratory Muscle Trainer
- K241040 — Amethyst HP PTA OTW 0.035 Catheter
- K241058 — Lyka® PORT Needle Free Access Device (4170Y)
- K241095 — ARTSMedia Semen Wash Medium
- K241132 — ARTSMedia Oocyte Aspiration Medium (502020, 502050, 502100)
- K241395 — Active System; Avenue8
- K242216 — GENTAFIX® (1, 3, 3MV)
- K242424 — Bluebird Single-Use Respiratory Effort Belt
- K242535 — Single-use Flexible Cystoscope (CY-E2E01, CY-E2E01R, CY-E2F01, CY-E2F01R, CY-E2G01, CY-E2G01R, CY-S2E01, CY-S2E01R) +1 more
- K242662 — Falcon/Xpress (Falcon/Xpress)
- K242787 — Tens & Ems Device (TU1080)
- K243128 — Klockner Kits
- K243609 — EquivaBone Osteoinductive Bone Graft Substitute (EquivaBone )
- K243615 — Physica Porous Femoral Components
- K243625 — Xpert MRSA/SA SSTI
- K243720 — 3Delta UNlimited
- K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent
- K240798 — Cntrl+ Bladder Support Pessary
- K241036 — Autoclave Indicator Tape; EO Indicator Tape
- K241556 — Cardiac Workstation (5000); Cardiac Workstation (7000)
- K241616 — ALLONUS Tech Prosthetics
- K241801 — Tornus ES
- K242146 — BIOBRANE Temporary Wound Dressing; BIOBRANE Glove
- K242297 — Reform Pedicle Screw System
- K242413 — VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens +1 more
- K242558 — Halyard Black Nitrile Powder-Free Exam Gloves with Textured Grip Technology, Tested for Use with Chemotherapy Drugs, Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid
- K242783 — Roche Digital Pathology Dx
- K242815 — POCKET TENS (EP-300)
- K242816 — Quantium
- K242869 — prodisc® L Instruments
- K242987 — Thulium Fiber Laser (FiberLAZE+, FiberLAZE)
- K243336 — Lucitone Digital Print Denture System
- K243365 — Healgen Accurate Muti-Drug Urine Drug Screen Cup; Healgen Accurate Home Muti-Drug Urine Test Cup
- K243664 — Sentinel Camera
- K232839 — Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
- K240676 — ULTIMUS Series Ultrasound Diagnostic System
- K240793 — MSKai
- K240809 — LUOFUCON® Silver Collagen Dressing
- K240873 — TEMBO Embolic System
- K240937 — AIM (N/A)
- K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set
- K242015 — TOPAZ Mobile X-ray System (Models : TOPAZ-32D, TOPAZ-40D)
- K242307 — ACHIEVE Partial Knee System
- K243066 — Dental Implants and Abutments
- K243471 — Extraction Basket
- K243641 — da Vinci Surgical System (IS5000)
- K242124 — Sim&Size
- K231424 — HeartBeam AIMIGo(TM) System
- K233001 — Bioscope Neuromonitor Device
- K233486 — 731 Series Ventilator
- K240778 — Vivo 1, Vivo 2
- K240779 — Vivo 3
- K240924 — Anterion
- K240998 — ABL90 FLEX PLUS System
- K241160 — CAIs Sensor (CAIs-001)
- K241998 — Ice Cooling IPL Hair Removal Device (UI20 DB, UI20 RE, UI20 GP, UI20 PW, UI20S DB, UI20S RE, UI20S PW, UI20S GP,UI20 WH, UI20 GR, UI20 BS, UI20 MP, UI20 BL, UI20 PN, UI20 BR, UI20WG, UI20S WH, UI20S GR, UI20S BS, UI20S MP)
- K242463 — ARIA Radiation Therapy Management System (18.1)
- K242487 — Laminar P1 (LDH-HW-001)
- K242532 — BTL-785BNF-E
- K242668 — Gastro Concepts Air Assist
- K243196 — Uro-G HD Cystoscope (1520)
- K243281 — LOCK-IN Spinal Fixation System
- K243307 — LCD Monitor (MDEC-2523)
- K243493 — Agilis NxT Steerable Introducer Dual-Reach
- K243560 — Remex Spine Surgery Navigation Instrument
- K243635 — aprevo® anterior lumbar interbody fusion device with interfixation
- K233152 — GENIOVA aligners
- K240735 — visio.lign color, visio.lign shield
- K241253 — Medicon Epiplating System
- K241271 — Aqua Medical RF Vapor Ablation System
- K241389 — Infrascanner Model 2500 (Model 2500)
- K242020 — EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System
- K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (PCD225-2) +1 more
- K242832 — NExT Station; NExT Station Advanced
- K242934 — Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
- K243495 — Natus Ultrapro S100 (982A0594)
- K243538 — uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)
- K243540 — Mac-Lab (AltiX AI.i); CardioLab (AltiX AI.i); ComboLab (AltiX AI.i); MLCL Client Software (AltiX AI.i)
- K240758 — Radiofrequency Generator System, Cura RF Electrode
- K241045 — Disposable Subdermal Needle Electrode, Corkscrew
- K241088 — EndoTool IV (3.1)
- K241219 — FiberLocker System: FiberLocker Implant (SpeedPatch PET), FiberLocker Instrument (FiberLocker Instrument SN)
- K241873 — OsseoFit Stemless Shoulder System
- K242033 — Access25 Delivery Microcatheter
- K242263 — TECHFIT DISRP® System
- K242378 — Eclipse Treatment Planning System (18.1)
Data sourced from openFDA. This site is unofficial and independent of the FDA.